Transdermal Patch

Novartis

Estracomb (estradiol 17b/ norethindrone acetate + estradiol 17b) is used to treat or prevent conditions due to menopause(hot flashes, vaginal itching, burning, dryness) and vulval or vaginal atrophy. It is also used for estrogen replacement therapy after failure of the ovaries, to relieve the symptoms of breast cancer in selected men and women, and to treat abnormal uterine bleeding due to hormone imbalance. It is also used to prevent osteoporosis (brittle bones) in women past menopause.

Do not take Estracomb (estradiol 17b/ norethindrone acetate + estradiol 17b) if you are allergic to Estracomb (estradiol 17b/ norethindrone acetate + estradiol 17b) you are pregnant or suspect you may be pregnant you have known or suspected breast cancer (unless directed by your doctor) or other cancers that are estrogen-dependent you have abnormal vaginal bleeding of unknown cause you have blood clots or vein inflammation

Before using Estracomb (estradiol 17b/ norethindrone acetate + estradiol 17b), tell your health care provider about any of the following: if you are pregnant, plan to become pregnant, or breastfeeding if you are taking any prescription medicine, nonprescription medicine, herbal preparation, or dietary supplement if you have heart disease or high blood pressure if you have diabetes if you have a family history of breast cancer if you have breast lumps, disease, or an abnormal mammogram if you have asthma if you have epilepsy if you have a history of migraine headaches if you have a family history of high cholesterol or high triglyceride levels if you have yellowing of the whites of the eyes or of the skin during pregnancy or during birth control pill use if you have impaired liver or kidney function if you have a vaginal infection if you have gallbladder disease if you have any other medical conditions

Estracomb (estradiol 17b/ norethindrone acetate + estradiol 17b) may increase the risk of cancer of the uterus in women past menopause. It should not be used during pregnancy due to an increased risk of birth defects in the sex organs of the fetus and possibly other birth defects. Estrogens represent a group of several female hormones. Normally the ovaries produce and release several natural estrogens until menopause occurs. All estrogens produce similar effects. Estracomb (estradiol 17b/ norethindrone acetate + estradiol 17b) plays a key role in the development and normal function of the reproductive system (including the vagina , uterus or womb, fallopian tubes and breasts) and secondary sex characteristics(eg, pubic hair) of women. Estracomb (estradiol 17b/ norethindrone acetate + estradiol 17b) also assists in the development and maintenance of strong bones.

Other:  Vaginal spotting; vaginal discharge; nausea; vomiting; breast tenderness or enlargement; fluid retention; spotty darkening of the skin, particularly on the face; dizziness; faintness; vision problems.

How much medicine you use and how often you use it depends on many factors, including the condition being treated and the age and weight of the patient. If you have any questions about the amount and/or frequency of Estracomb (estradiol 17b/ norethindrone acetate + estradiol 17b) you are using, talk with your health care provider. You will need to have a complete medical and family history examination before using Estracomb (estradiol 17b/ norethindrone acetate + estradiol 17b). If you are switching from oral estrogen to Estracomb (estradiol 17b/ norethindrone acetate + estradiol 17b), stop taking the oral medicine and wait 1 week before using Estracomb (estradiol 17b/ norethindrone acetate + estradiol 17b). However, if symptoms return, you may start using Estracomb (estradiol 17b/ norethindrone acetate + estradiol 17b) sooner. The adhesive side of the transdermal system should be placed on a clean, dry area of the lower abdomen or the upper part of the buttock. Never apply to the breasts. Apply the new system on a different site than the previous one. Be sure to allow at least 1 week before applying the system to a previously used site. Make sure the application site is not oily, damaged or irritated. Do not apply to the waistband area; tight clothing may rub and remove the system. Avoid applying to areas where sitting might dislodge the system. Apply the system immediately after opening the pouch and removing the protective liner. Press the system firmly in place with the fingers for about 10 seconds, making sure that there is good contact especially around the edges. If the system lifts, press down to reapply. Wear only 1 system at any one time. Change the system once a week. Contact with water when bathing, swimming, or showering will not affect the system. If the system falls off, a new system should be applied for the remainder of the 7-day dosing interval. Contact your doctor if you are pregnant, become pregnant or are planning to become pregnant. Use non-hormonal birth control measures to avoid birth defects. Estracomb (estradiol 17b/ norethindrone acetate + estradiol 17b) may increase the risk of endometrial cancer. Your doctor may prescribe another hormone (eg, progestin) to decrease this risk. Women taking Estracomb (estradiol 17b/ norethindrone acetate + estradiol 17b) should examine their breasts regularly. Contact your health care provider if vaginal bleeding of unknown cause occurs. This could be a sign of a serious condition requiring immediate medical attention. Contact your doctor immediately if any of the following occurs: Abnormal vaginal bleeding; pains in calves or chest; sudden shortness of breath; coughing of blood; severe headache or vomiting; dizziness; faintness; changes in vision or speech; weakness or numbness of an arm or leg; breast lumps; yellowing of the skin or eyes; pain, swelling, or tenderness in the stomach. Contact your health care provider if vaginal discomfort occurs or if you suspect you have developed an infection while taking Estracomb (estradiol 17b/ norethindrone acetate + estradiol 17b). Estracomb (estradiol 17b/ norethindrone acetate + estradiol 17b) may cause dizziness. Use caution while driving or performing other tasks requiring alertness, coordination, or physical dexterity. Lab tests will be required to monitor therapy. You will need to have follow-up exams at least once a year. Be sure to keep appointments. Do not stop using Estracomb (estradiol 17b/ norethindrone acetate + estradiol 17b) without checking with your doctor. Do not use more medicine than prescribed unless advised to do so by your doctor or health care provider. Do not take any other over-the-counter or prescription medications without talking with your health care provider. This includes any herbal preparations or dietary supplements. If a dose is missed, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your doctor. If more than one dose is missed, restart medication and advise your doctor or pharmacist at your next appointment.

Store Estracomb (estradiol 17b/ norethindrone acetate + estradiol 17b) below 86 degrees F. Keep in pouch until ready for use. Immediately apply patch once package is opened.